The document describes the system suitability testing for Tramadol quality control using the Agilent 1120 Compact LC and ZORBAX C-18 columns. The system demonstrates excellent retention time precision and peak area precision, making it suitable for drug analysis.
The document describes an analytical method to evaluate the performance of the Agilent 1120 Compact LC system. It focuses on system suitability testing (SST) for the quantification of the analgesic drug Tramadol and potential synthesis byproducts, including starting materials like 3-bromoanisole.
| Column dimensions | 250 x 4.6 mm |
|---|---|
| Particle size | 5 µm |
| Flow rate | 1.2 mL/min |
| Injection volume | 10 µL |
| Column oven temperature | 30 °C |
| Detection wavelength | 270 nm |
The relative standard deviation (RSD) of retention time must be less than 0.07 %.
The resolution between peaks must be greater than 2.00.
The system must demonstrate more than 2000 theoretical plates.